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Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia (ADVANCE-2)

Primary Purpose

Schizophrenia

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pimavanserin
Placebo
Sponsored by
ACADIA Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female, ≥18 and ≤55 years of age at the time of Screening
  • Has a caregiver or some other identified responsible person (e.g., family member, social worker, caseworker, or nurse) considered reliable by the Investigator in providing support to the subject to help ensure compliance with study treatment, study visits, and protocol procedures, and who is also able to provide input helpful for completing study rating scales
  • Diagnosis of schizophrenia made ≥1 year prior to Screening

  • Is being treated must be one of the antipsychotics listed below:

    • Aripiprazole

      • Aripiprazole long-acting injectables
      • Abilify Maintena®
    • Aristada®
    • Asenapine
    • Brexpiprazole
    • Cariprazine
    • Lurasidone
    • Olanzapine
    • Paliperidone extended release (ER) (≤9 mg)

    • Paliperidone palmitate

      • Invega Sustenna® (≤156 mg)
      • Invega Trinza® (≤546 mg)
      • Trevicta® (≤350 mg)
      • Xeplion® (≤100 mg)
    • Risperidone
    • Risperidone long-acting injection
  • Must be medically stable (including no recent hospitalization for exacerbation of psychiatric disorder) and has been medically stable for at least 12 weeks prior to Screening, in the opinion of the Investigator

Exclusion Criteria:

  • Has a current comorbid psychiatric disorder other than schizophrenia or a disorder that would interfere with the ability to complete study assessments
  • Is at a significant risk of suicide, in the opinion of the Investigator
  • Has a significant risk of violent behavior in the opinion of the Investigator
  • A confirmed urine drug screen (UDS) result at Baseline that indicates the presence of any tested prohibited substance of potential abuse, including marijuana
  • Is taking a medication or drug or other substance that is prohibited according to this protocol, including medications that prolong the QT interval, strong cytochrome P450 (CYP) 3A4 enzyme (CYP3A4) inhibitors and inducers
  • Known family or personal history or symptoms of long QT syndrome or risk factors for torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval
  • Current evidence, or history within the previous 12 weeks prior to Screening, of a serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies that in the judgment of the Investigator would jeopardize the safe participation of the subject in the study
  • Has moderate to severe congestive heart failure
  • Has a history of myocardial infarction within 6 months prior to enrollment
  • Has a body mass index (BMI) <19 or ≥35 at Screening

Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and condition do not meet all prespecified entry criteria).

Sites / Locations

  • 610-Clinica Privada Banfield S.A.
  • 601-CENydET- Centro Neurobiologico y de Estres Traumatico-Biopsychomedical Research Group SRL
  • 602-FunDamoS
  • 603-Fundación para el Estudio y Tratamiento de las Enfermedades Mentales - FETEM
  • 625-NOVAIN Neurociencias Group
  • 607-Resolution Psicopharmacology Research Institute
  • 624-Centro Especializado en Neurociencias CEN
  • 622-Instituto Medico Damic Srl
  • 626-Sanatorio Prof. Leon S. Morra S.A.
  • 617-INSA Instituto de Neurociencias San Agustin S.A.
  • 623-Clinica Privada de Salud Mental Santa Teresa de Avila
  • 532-MHAT "Dr. Hristo Stambolski", EOOD
  • 454-Mental Health Center Prof. Dr. Ivan Temkov - Burgas EO Burgas; Department for Treatment of Emergency Psychiatric Conditions
  • 533-State Psychiatric Hospital - Kardzhali, EOOD
  • 569-State Psychiatric Hospital - Lovech
  • 535-UMHAT 'Dr. Georgi Stranski', EAD
  • 586-Medical Center Mentalcare OOD
  • 563-MC-Hipokrat-N E00D
  • 592-Medical center Spectar - Plovdiv EOOD
  • 570-Medical Centre "Sveti Naum"
  • 526-DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan", OOD
  • 405-"UMHAT Alexandrovska EAD, Sofia; Clinic of Psychiatry, First Department of Psychiatry "
  • 568-Medical Center Hera EOOD
  • 528-Medical Center Intermedica, OOD
  • 590-State Psychiatric Hospital - Tzarev Brod
  • 498-DCC "Mladost M" - Varna, OOD
  • 455-Mental Health Center - Veliko Tarnovo EOOD,
  • 401-Mental Health Center - Vratsa EOOD, Vratsa; Department of Psychiatry
  • 536-Clinic for psychiatry Vrapce
  • 537-Clinic for psychiatry Vrapce
  • 550-Clinic for psychiatry Vrapce
  • 557-Clinic for psychiatry Vrapce
  • 594-klinika za psihijatriju Sveti Ivan, n/p Igor Filipčić or Marija Zelenika
  • 512-NeuropsychiatrieHK s.r.o.
  • 583-Narodni ustav dusevniho zdravi
  • 519-A-SHINE s.r.o.
  • 513-CLINTRIAL s.r.o.
  • 499-MUDr. Tibor Miklos
  • 410-Mathe es Tarsa Bt.
  • 456-Semmelweis University Department of Psychiatry and Psychotherapy
  • 520-Nyiro Gyula Korhaz - Orszagos Pszichiatriai es Addiktologiai Intezet
  • 440-PsychoTech Kft.
  • 580-AOU Consorziale Policlinico di Bari
  • 539-"Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico U.O.C. Psichiatria - Padiglione Alfieri, primo piano"
  • 566-Ospedale San Raffaele (San Raffaele Turro)
  • 553-AO Città della Salute e della Scienza di Torino
  • 516-Neuromeda, JSC
  • 483-Romuvos klinika, UAB
  • 518-Kaunas City Outpatient Clinic, Public Institution
  • 484-Medical Center Puriena JSC
  • 525-Podlaskie Centrum Psychogeriatrii
  • 502-Przychodnia Srodmiescie Sp. z o. o.
  • 579-Centrum Badan Klinicznych P.I. House Sp. z o.o.
  • 541-Care Clinic centrum Medyczne
  • 501-Specjalistyczna Praktyka Lekarska Marek Domański
  • 578-MSCZ im. prof. J. Mazurkiewicza
  • 540-Ośr. Badań Klin. CLINSANTE S.C.
  • 417-State budget healthcare Institution of Stavropol region "Regional specialized psychiatric hospital #2".
  • 505-GUZ Lipetsk Regional psychoneurological Hospital #1
  • 573-"SBIH of Moscow ""Psychiatric Clinical Hospital # 4 n.a. P.B. Gannushkin"" Short name: PCH N4 n.a. P.B.Gannushkin"
  • 581-SBIH of Moscow "Psych Clinical Hospital #1 N.A. Alekseev"
  • 415-Saint-Petersburg state healthcare institution "Saint Nicolas wonderworker psychiatric hospital"
  • 451-V. M. Bekhterev National Research Medical Center For Psychiatry and Neurology
  • 465-"Saint-Petersburg Scientific Research Psychoneurological Institute n.a. V.M. Bekhterev
  • 495-"FSBI "National medical scientific center of psychiatry and neurology n.a. V.M. Bekhterev" MoH Short name: NMSC of Psy&Neuro n.a. Bekhterev, 12 dep."
  • 464-Saint Petersburg State Budget Healthcare Institution "City Psychiatric Hospital No. 6 (Inpatient Department with Treatment Center)
  • 452-Saint Petersburg State Public Institution of Healthcare "City Psychiatric Hospital #3 n.a. I. I. Skvortsov-Stepanov",
  • 571-St. Petersburg SHI "Psychoneurological Dispensary #10"
  • 453-"Saint-Petersburg Scientific Research Psychoneurological Institute n.a. V.M. Bekhterev"
  • 444-SPHI "City Mental Hospital #3 n.a. I.I.Skvortsov-Stepanov"
  • 496-SPHI "City Mental Hospital #3 n.a. I.I.Skvortsov-Stepanov"
  • 458-State Budget Healthcare Institution "Samara Psychiatric Hospital
  • 416-FSBEI HE "Smolensk State Medical University" of the MoH of the RF (Clinical Research Centre of diagnostics and medicines)
  • 572-Klinika StoLet" Ltd.
  • 422-State Budget healthcare Institution of Yaroslavl region "Yaroslavl region clinical psychiatric hospital"
  • 424-Institute of Mental health
  • 425-Clinical Hospital Center "Dr. Dragisa Misovic-Dedinje", Clinic of Psychiatry
  • 584-Clinic for Psychiatry, Clinical Canter of Serbia
  • 587-Institute of Mental health
  • 472-Special Neuropsychiatric Hospital Kovin
  • 430-Psychiatric Clinic, Clinical Center Kragujevac
  • 423-Clinical Center Kragujevac, Clinic of Psychiatry
  • 427-Clinical Center Nis, Mental Health Protection Clinic
  • 585-Special Hospital for Psychiatric Diseases "Gornja Toponica"
  • 593-Specialized Hospital for Neuropsychiatric Diseases "Sveti Vracevi"
  • 574-Hospital Clinic de Barcelona
  • 576-Hospital Universitari Vall d'Hebron
  • 588-Institucion Hospitalaria Hestia Palau - Ensayos clinicos
  • 475-Hospital Gregorio Marañon
  • 575-Hospital Universitario 12 de Octubre
  • 494-CSM La Corredoria
  • 431-Hospital Psiquiátrico Provincial Doctor Villacian
  • 529-Hospital Provincial de Zamora
  • 508-CI Cherkasy Regional Psychiatric Hospital of ChRC
  • 564-Regional Clinical Psychiatric Hospital
  • 460-Kyiv City Psychoneurological Hospital #3 General Psychiatry Department No. 2
  • 434-State Institution "Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine", Department of Urgent Psychiatry and Narcology
  • 567-"CIH Kharkiv Regional Clinical Psychiatric Hospital #3 Psychiatric Department of Primary Psychotic Episod Short Site name: CIH KRCPH #3 PD of PPE "
  • 582-SI Institute of Neurology,Psychiatry&Narcology of NAMSU
  • 435-Kyiv Regional Medical Incorporation "Psychiatry". Center of Novel Treatment and Rehabilitation of Psychotic disorders, build 5, Department #30
  • 565-"Kyiv CH on Railway Transport #2 of Branch Center of Healthcare Public Company Ukr Railway Short site name: Kyiv Railway Clinical Hospital № 2"
  • 509-CI Odesa Regional Medical Centre of Mental Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Drug - Pimavanserin

Placebo

Arm Description

Pimavanserin 34 mg taken as two tablets + background antipsychotic, once daily by mouth

Placebo + background antipsychotic, taken as two tablets, once daily by mouth

Outcomes

Primary Outcome Measures

Negative Symptom Assessment-16 (NSA-16) total score - change from Baseline to Week 26
The NSA-16 is a 16-item scale that can be completed in approximately 15 to 20 minutes. The NSA-16 has been validated for the assessment of the negative symptoms of schizophrenia and assesses 5 domains of negative symptoms: (1) communication, (2) emotion/affect, (3) social involvement, (4) motivation, and (5) retardation.

Secondary Outcome Measures

Clinical Global Impression of Schizophrenia Scale-Severity (CGI-SCH-S) of negative symptoms score - change from Baseline to Week 26
The CGI-SCH-S is a clinician-rated, 7-point scale that is designed to evaluate positive, negative, depressive, cognitive symptoms, and overall severity in schizophrenia. For the purposes of this study, only the negative symptoms will be evaluated.
Clinical Global Impression of Schizophrenia Scale-Improvement (CGI-SCH-I) of negative symptoms score at Week 26
The CGI-SCH-I is a clinician-rated, 7-point scale that is designed to evaluate change in positive, negative, depressive, cognitive symptoms, and overall severity in schizophrenia. For the purposes of this study, only the negative symptoms will be evaluated.
Proportion of CGI-SCH-I of negative symptoms responders (CGI-SCH-I of negative symptoms score of 1 or 2) at Week 26
The CGI-SCH-I is a clinician-rated, 7-point scale that is designed to evaluate change in positive, negative, depressive, cognitive symptoms, and overall severity in schizophrenia. For the purposes of this study, only the negative symptoms will be evaluated.
Personal and Social Performance (PSP) scale score - change from Baseline to Week 26
The PSP is a validated, 100-point, single-item rating scale to assess the psychosocial functioning of subjects with schizophrenia. Ratings are based on the assessment of subject functioning across four domains of socially useful activities (e.g., work and study, personal and social relationships, self-care, and disturbing and aggressive behavior).
Proportion of NSA-16 responders (≥20%and ≥30% reduction in NSA-16 total score) at Week 26
The NSA-16 is a 16-item scale that can be completed in approximately 15 to 20 minutes. The NSA-16 has been validated for the assessment of the negative symptoms of schizophrenia and assesses 5 domains of negative symptoms: (1) communication, (2) emotion/affect, (3) social involvement, (4) motivation, and (5) retardation.
Positive and Negative Syndrome Scale (PANSS) total score - change from Baseline to Week 26
The PANSS is a 30-item scale used to evaluate the presence, absence, and severity of schizophrenia symptoms. The 30 items are arranged as 7 positive symptom items, 7 negative symptom items, and 16 general psychopathology symptom items. The PANSS total score can range from a minimum of 30 to a maximum of 210.
PANSS negative subscores - change from Baseline to Week 26
The PANSS is a 30-item scale used to evaluate the presence, absence, and severity of schizophrenia symptoms. The 30 items are arranged as 7 positive symptom items, 7 negative symptom items, and 16 general psychopathology symptom items. The PANSS total score can range from a minimum of 30 to a maximum of 210.
PANSS Marder factor (negative symptoms) score - change from Baseline to Week 26
The PANSS is a 30-item scale used to evaluate the presence, absence, and severity of schizophrenia symptoms. The 30 items are arranged as 7 positive symptom items, 7 negative symptom items, and 16 general psychopathology symptom items. The PANSS total score can range from a minimum of 30 to a maximum of 210.

Full Information

First Posted
August 26, 2020
Last Updated
August 15, 2023
Sponsor
ACADIA Pharmaceuticals Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04531982
Brief Title
Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia
Acronym
ADVANCE-2
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 5, 2020 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ACADIA Pharmaceuticals Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the efficacy and safety of adjunctive pimavanserin compared with adjunctive placebo in the treatment of negative symptoms of schizophrenia

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
454 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug - Pimavanserin
Arm Type
Experimental
Arm Description
Pimavanserin 34 mg taken as two tablets + background antipsychotic, once daily by mouth
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo + background antipsychotic, taken as two tablets, once daily by mouth
Intervention Type
Drug
Intervention Name(s)
Pimavanserin
Intervention Description
Pimavanserin 34 mg, taken as two blinded 17 mg tablets once daily by mouth
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, taken as two blinded tablets once daily by mouth
Primary Outcome Measure Information:
Title
Negative Symptom Assessment-16 (NSA-16) total score - change from Baseline to Week 26
Description
The NSA-16 is a 16-item scale that can be completed in approximately 15 to 20 minutes. The NSA-16 has been validated for the assessment of the negative symptoms of schizophrenia and assesses 5 domains of negative symptoms: (1) communication, (2) emotion/affect, (3) social involvement, (4) motivation, and (5) retardation.
Time Frame
26 Weeks Treatment Duration
Secondary Outcome Measure Information:
Title
Clinical Global Impression of Schizophrenia Scale-Severity (CGI-SCH-S) of negative symptoms score - change from Baseline to Week 26
Description
The CGI-SCH-S is a clinician-rated, 7-point scale that is designed to evaluate positive, negative, depressive, cognitive symptoms, and overall severity in schizophrenia. For the purposes of this study, only the negative symptoms will be evaluated.
Time Frame
26 Weeks Treatment Duration
Title
Clinical Global Impression of Schizophrenia Scale-Improvement (CGI-SCH-I) of negative symptoms score at Week 26
Description
The CGI-SCH-I is a clinician-rated, 7-point scale that is designed to evaluate change in positive, negative, depressive, cognitive symptoms, and overall severity in schizophrenia. For the purposes of this study, only the negative symptoms will be evaluated.
Time Frame
26 Weeks Treatment Duration
Title
Proportion of CGI-SCH-I of negative symptoms responders (CGI-SCH-I of negative symptoms score of 1 or 2) at Week 26
Description
The CGI-SCH-I is a clinician-rated, 7-point scale that is designed to evaluate change in positive, negative, depressive, cognitive symptoms, and overall severity in schizophrenia. For the purposes of this study, only the negative symptoms will be evaluated.
Time Frame
26 Weeks Treatment Duration
Title
Personal and Social Performance (PSP) scale score - change from Baseline to Week 26
Description
The PSP is a validated, 100-point, single-item rating scale to assess the psychosocial functioning of subjects with schizophrenia. Ratings are based on the assessment of subject functioning across four domains of socially useful activities (e.g., work and study, personal and social relationships, self-care, and disturbing and aggressive behavior).
Time Frame
26 Weeks Treatment Duration
Title
Proportion of NSA-16 responders (≥20%and ≥30% reduction in NSA-16 total score) at Week 26
Description
The NSA-16 is a 16-item scale that can be completed in approximately 15 to 20 minutes. The NSA-16 has been validated for the assessment of the negative symptoms of schizophrenia and assesses 5 domains of negative symptoms: (1) communication, (2) emotion/affect, (3) social involvement, (4) motivation, and (5) retardation.
Time Frame
26 Weeks Treatment Duration
Title
Positive and Negative Syndrome Scale (PANSS) total score - change from Baseline to Week 26
Description
The PANSS is a 30-item scale used to evaluate the presence, absence, and severity of schizophrenia symptoms. The 30 items are arranged as 7 positive symptom items, 7 negative symptom items, and 16 general psychopathology symptom items. The PANSS total score can range from a minimum of 30 to a maximum of 210.
Time Frame
26 Weeks Treatment Duration
Title
PANSS negative subscores - change from Baseline to Week 26
Description
The PANSS is a 30-item scale used to evaluate the presence, absence, and severity of schizophrenia symptoms. The 30 items are arranged as 7 positive symptom items, 7 negative symptom items, and 16 general psychopathology symptom items. The PANSS total score can range from a minimum of 30 to a maximum of 210.
Time Frame
26 Weeks Treatment Duration
Title
PANSS Marder factor (negative symptoms) score - change from Baseline to Week 26
Description
The PANSS is a 30-item scale used to evaluate the presence, absence, and severity of schizophrenia symptoms. The 30 items are arranged as 7 positive symptom items, 7 negative symptom items, and 16 general psychopathology symptom items. The PANSS total score can range from a minimum of 30 to a maximum of 210.
Time Frame
26 Weeks Treatment Duration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, ≥18 and ≤55 years of age at the time of Screening Has a caregiver or some other identified responsible person (e.g., family member, social worker, caseworker, or nurse) considered reliable by the Investigator in providing support to the subject to help ensure compliance with study treatment, study visits, and protocol procedures, and who is also able to provide input helpful for completing study rating scales Diagnosis of schizophrenia made ≥1 year prior to Screening Is being treated must be one of the antipsychotics listed below: Aripiprazole Aripiprazole long-acting injectables Abilify Maintena® Aristada® Asenapine Brexpiprazole Cariprazine Lurasidone Olanzapine Paliperidone extended release (ER) (≤9 mg) Paliperidone palmitate Invega Sustenna® (≤156 mg) Invega Trinza® (≤546 mg) Trevicta® (≤350 mg) Xeplion® (≤100 mg) Risperidone Risperidone long-acting injection Must be medically stable (including no recent hospitalization for exacerbation of psychiatric disorder) and has been medically stable for at least 12 weeks prior to Screening, in the opinion of the Investigator Exclusion Criteria: Has a current comorbid psychiatric disorder other than schizophrenia or a disorder that would interfere with the ability to complete study assessments Is at a significant risk of suicide, in the opinion of the Investigator Has a significant risk of violent behavior in the opinion of the Investigator A confirmed urine drug screen (UDS) result at Baseline that indicates the presence of any tested prohibited substance of potential abuse, including marijuana Is taking a medication or drug or other substance that is prohibited according to this protocol, including medications that prolong the QT interval, strong cytochrome P450 (CYP) 3A4 enzyme (CYP3A4) inhibitors and inducers Known family or personal history or symptoms of long QT syndrome or risk factors for torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval Current evidence, or history within the previous 12 weeks prior to Screening, of a serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies that in the judgment of the Investigator would jeopardize the safe participation of the subject in the study Has moderate to severe congestive heart failure Has a history of myocardial infarction within 6 months prior to enrollment Has a body mass index (BMI) <19 or ≥35 at Screening Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and condition do not meet all prespecified entry criteria).
Facility Information:
Facility Name
610-Clinica Privada Banfield S.A.
City
Buenos Aires
Country
Argentina
Facility Name
601-CENydET- Centro Neurobiologico y de Estres Traumatico-Biopsychomedical Research Group SRL
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
1058 AAJ
Country
Argentina
Facility Name
602-FunDamoS
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1405BOA
Country
Argentina
Facility Name
603-Fundación para el Estudio y Tratamiento de las Enfermedades Mentales - FETEM
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1133AAH
Country
Argentina
Facility Name
625-NOVAIN Neurociencias Group
City
Ciudad Autonoma de Buenos Aires
Country
Argentina
Facility Name
607-Resolution Psicopharmacology Research Institute
City
Ciudad de Mendoza
ZIP/Postal Code
5502
Country
Argentina
Facility Name
624-Centro Especializado en Neurociencias CEN
City
Cordoba
Country
Argentina
Facility Name
622-Instituto Medico Damic Srl
City
Córdoba
Country
Argentina
Facility Name
626-Sanatorio Prof. Leon S. Morra S.A.
City
Córdoba
Country
Argentina
Facility Name
617-INSA Instituto de Neurociencias San Agustin S.A.
City
La Plata
Country
Argentina
Facility Name
623-Clinica Privada de Salud Mental Santa Teresa de Avila
City
La Plata
Country
Argentina
Facility Name
532-MHAT "Dr. Hristo Stambolski", EOOD
City
Kazanlak
State/Province
Stara Zagora
ZIP/Postal Code
6100
Country
Bulgaria
Facility Name
454-Mental Health Center Prof. Dr. Ivan Temkov - Burgas EO Burgas; Department for Treatment of Emergency Psychiatric Conditions
City
Burgas
ZIP/Postal Code
8000
Country
Bulgaria
Facility Name
533-State Psychiatric Hospital - Kardzhali, EOOD
City
Kardzhali
ZIP/Postal Code
6600
Country
Bulgaria
Facility Name
569-State Psychiatric Hospital - Lovech
City
Lovech
ZIP/Postal Code
5500
Country
Bulgaria
Facility Name
535-UMHAT 'Dr. Georgi Stranski', EAD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
586-Medical Center Mentalcare OOD
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Facility Name
563-MC-Hipokrat-N E00D
City
Plovdiv
ZIP/Postal Code
4028
Country
Bulgaria
Facility Name
592-Medical center Spectar - Plovdiv EOOD
City
Plovdiv
Country
Bulgaria
Facility Name
570-Medical Centre "Sveti Naum"
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
526-DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan", OOD
City
Sofia
ZIP/Postal Code
1408
Country
Bulgaria
Facility Name
405-"UMHAT Alexandrovska EAD, Sofia; Clinic of Psychiatry, First Department of Psychiatry "
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
568-Medical Center Hera EOOD
City
Sofia
ZIP/Postal Code
1510
Country
Bulgaria
Facility Name
528-Medical Center Intermedica, OOD
City
Sofia
ZIP/Postal Code
1680
Country
Bulgaria
Facility Name
590-State Psychiatric Hospital - Tzarev Brod
City
Tsarev Brod
Country
Bulgaria
Facility Name
498-DCC "Mladost M" - Varna, OOD
City
Varna
ZIP/Postal Code
9020
Country
Bulgaria
Facility Name
455-Mental Health Center - Veliko Tarnovo EOOD,
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
401-Mental Health Center - Vratsa EOOD, Vratsa; Department of Psychiatry
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
Facility Name
536-Clinic for psychiatry Vrapce
City
Zagreb
ZIP/Postal Code
10090
Country
Croatia
Facility Name
537-Clinic for psychiatry Vrapce
City
Zagreb
ZIP/Postal Code
10090
Country
Croatia
Facility Name
550-Clinic for psychiatry Vrapce
City
Zagreb
ZIP/Postal Code
10090
Country
Croatia
Facility Name
557-Clinic for psychiatry Vrapce
City
Zagreb
ZIP/Postal Code
10090
Country
Croatia
Facility Name
594-klinika za psihijatriju Sveti Ivan, n/p Igor Filipčić or Marija Zelenika
City
Zagreb
Country
Croatia
Facility Name
512-NeuropsychiatrieHK s.r.o.
City
Hradec Králové
ZIP/Postal Code
503 41
Country
Czechia
Facility Name
583-Narodni ustav dusevniho zdravi
City
Klecany
ZIP/Postal Code
25067
Country
Czechia
Facility Name
519-A-SHINE s.r.o.
City
Plzen
ZIP/Postal Code
31200
Country
Czechia
Facility Name
513-CLINTRIAL s.r.o.
City
Praha 10
ZIP/Postal Code
100 00
Country
Czechia
Facility Name
499-MUDr. Tibor Miklos
City
Praha 10
ZIP/Postal Code
106 00
Country
Czechia
Facility Name
410-Mathe es Tarsa Bt.
City
Kalocsa
State/Province
Bacs
ZIP/Postal Code
6300
Country
Hungary
Facility Name
456-Semmelweis University Department of Psychiatry and Psychotherapy
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
520-Nyiro Gyula Korhaz - Orszagos Pszichiatriai es Addiktologiai Intezet
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
440-PsychoTech Kft.
City
Pecs
ZIP/Postal Code
7633
Country
Hungary
Facility Name
580-AOU Consorziale Policlinico di Bari
City
Bari
Country
Italy
Facility Name
539-"Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico U.O.C. Psichiatria - Padiglione Alfieri, primo piano"
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
566-Ospedale San Raffaele (San Raffaele Turro)
City
Milano
ZIP/Postal Code
20127
Country
Italy
Facility Name
553-AO Città della Salute e della Scienza di Torino
City
Torino
Country
Italy
Facility Name
516-Neuromeda, JSC
City
Kaunas
ZIP/Postal Code
50185
Country
Lithuania
Facility Name
483-Romuvos klinika, UAB
City
Kaunas
ZIP/Postal Code
LT-44279
Country
Lithuania
Facility Name
518-Kaunas City Outpatient Clinic, Public Institution
City
Kaunas
ZIP/Postal Code
LT-48259
Country
Lithuania
Facility Name
484-Medical Center Puriena JSC
City
Silute
Country
Lithuania
Facility Name
525-Podlaskie Centrum Psychogeriatrii
City
Bialystok
ZIP/Postal Code
15-756
Country
Poland
Facility Name
502-Przychodnia Srodmiescie Sp. z o. o.
City
Bydgoszcz
ZIP/Postal Code
85-080
Country
Poland
Facility Name
579-Centrum Badan Klinicznych P.I. House Sp. z o.o.
City
Gdańsk
ZIP/Postal Code
80-546
Country
Poland
Facility Name
541-Care Clinic centrum Medyczne
City
Katowice
ZIP/Postal Code
40-568
Country
Poland
Facility Name
501-Specjalistyczna Praktyka Lekarska Marek Domański
City
Lublin
ZIP/Postal Code
20-582
Country
Poland
Facility Name
578-MSCZ im. prof. J. Mazurkiewicza
City
Pruszków
ZIP/Postal Code
05-802
Country
Poland
Facility Name
540-Ośr. Badań Klin. CLINSANTE S.C.
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
417-State budget healthcare Institution of Stavropol region "Regional specialized psychiatric hospital #2".
City
Tonnel'nyy
State/Province
Stavropol Region
ZIP/Postal Code
357034
Country
Russian Federation
Facility Name
505-GUZ Lipetsk Regional psychoneurological Hospital #1
City
Lipetsk
ZIP/Postal Code
398007
Country
Russian Federation
Facility Name
573-"SBIH of Moscow ""Psychiatric Clinical Hospital # 4 n.a. P.B. Gannushkin"" Short name: PCH N4 n.a. P.B.Gannushkin"
City
Moscow
ZIP/Postal Code
107076
Country
Russian Federation
Facility Name
581-SBIH of Moscow "Psych Clinical Hospital #1 N.A. Alekseev"
City
Moscow
ZIP/Postal Code
117152
Country
Russian Federation
Facility Name
415-Saint-Petersburg state healthcare institution "Saint Nicolas wonderworker psychiatric hospital"
City
Saint Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
451-V. M. Bekhterev National Research Medical Center For Psychiatry and Neurology
City
Saint Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
465-"Saint-Petersburg Scientific Research Psychoneurological Institute n.a. V.M. Bekhterev
City
Saint Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
495-"FSBI "National medical scientific center of psychiatry and neurology n.a. V.M. Bekhterev" MoH Short name: NMSC of Psy&Neuro n.a. Bekhterev, 12 dep."
City
Saint Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
464-Saint Petersburg State Budget Healthcare Institution "City Psychiatric Hospital No. 6 (Inpatient Department with Treatment Center)
City
Saint Petersburg
ZIP/Postal Code
193167
Country
Russian Federation
Facility Name
452-Saint Petersburg State Public Institution of Healthcare "City Psychiatric Hospital #3 n.a. I. I. Skvortsov-Stepanov",
City
Saint Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
571-St. Petersburg SHI "Psychoneurological Dispensary #10"
City
Saint-Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
453-"Saint-Petersburg Scientific Research Psychoneurological Institute n.a. V.M. Bekhterev"
City
Saint-Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
444-SPHI "City Mental Hospital #3 n.a. I.I.Skvortsov-Stepanov"
City
Saint-Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
496-SPHI "City Mental Hospital #3 n.a. I.I.Skvortsov-Stepanov"
City
Saint-Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
458-State Budget Healthcare Institution "Samara Psychiatric Hospital
City
Samara
ZIP/Postal Code
443016
Country
Russian Federation
Facility Name
416-FSBEI HE "Smolensk State Medical University" of the MoH of the RF (Clinical Research Centre of diagnostics and medicines)
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
572-Klinika StoLet" Ltd.
City
Tomsk
ZIP/Postal Code
634009
Country
Russian Federation
Facility Name
422-State Budget healthcare Institution of Yaroslavl region "Yaroslavl region clinical psychiatric hospital"
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
424-Institute of Mental health
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
425-Clinical Hospital Center "Dr. Dragisa Misovic-Dedinje", Clinic of Psychiatry
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
584-Clinic for Psychiatry, Clinical Canter of Serbia
City
Belgrade
Country
Serbia
Facility Name
587-Institute of Mental health
City
Belgrade
Country
Serbia
Facility Name
472-Special Neuropsychiatric Hospital Kovin
City
Kovin
Country
Serbia
Facility Name
430-Psychiatric Clinic, Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
423-Clinical Center Kragujevac, Clinic of Psychiatry
City
Kragujevac
Country
Serbia
Facility Name
427-Clinical Center Nis, Mental Health Protection Clinic
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
585-Special Hospital for Psychiatric Diseases "Gornja Toponica"
City
Niš
Country
Serbia
Facility Name
593-Specialized Hospital for Neuropsychiatric Diseases "Sveti Vracevi"
City
Novi Kneževac
Country
Serbia
Facility Name
574-Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
576-Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
588-Institucion Hospitalaria Hestia Palau - Ensayos clinicos
City
Barcelona
Country
Spain
Facility Name
475-Hospital Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
575-Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
494-CSM La Corredoria
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Facility Name
431-Hospital Psiquiátrico Provincial Doctor Villacian
City
Valladolid
ZIP/Postal Code
47016
Country
Spain
Facility Name
529-Hospital Provincial de Zamora
City
Zamora
ZIP/Postal Code
49021
Country
Spain
Facility Name
508-CI Cherkasy Regional Psychiatric Hospital of ChRC
City
Smila
State/Province
Cherkas'ka Oblast
ZIP/Postal Code
20708
Country
Ukraine
Facility Name
564-Regional Clinical Psychiatric Hospital
City
Kropyvnytskyi
State/Province
Kirovograd Region
ZIP/Postal Code
25491
Country
Ukraine
Facility Name
460-Kyiv City Psychoneurological Hospital #3 General Psychiatry Department No. 2
City
Kyiv
State/Province
Vasylkiv District Kyiv Region
ZIP/Postal Code
08631
Country
Ukraine
Facility Name
434-State Institution "Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine", Department of Urgent Psychiatry and Narcology
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
567-"CIH Kharkiv Regional Clinical Psychiatric Hospital #3 Psychiatric Department of Primary Psychotic Episod Short Site name: CIH KRCPH #3 PD of PPE "
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
582-SI Institute of Neurology,Psychiatry&Narcology of NAMSU
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
435-Kyiv Regional Medical Incorporation "Psychiatry". Center of Novel Treatment and Rehabilitation of Psychotic disorders, build 5, Department #30
City
Kyiv
ZIP/Postal Code
04080
Country
Ukraine
Facility Name
565-"Kyiv CH on Railway Transport #2 of Branch Center of Healthcare Public Company Ukr Railway Short site name: Kyiv Railway Clinical Hospital № 2"
City
Kyiv
ZIP/Postal Code
3049
Country
Ukraine
Facility Name
509-CI Odesa Regional Medical Centre of Mental Health
City
Odesa
ZIP/Postal Code
65014
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36190440
Citation
Darwish M, Bugarski-Kirola D, Passarell J, Owen J, Jaworowicz D, DeKarske D, Stankovic S. Pimavanserin Exposure-Response Analyses in Patients With Schizophrenia: Results From the Phase 2 ADVANCE Study. J Clin Psychopharmacol. 2022 Nov-Dec 01;42(6):544-551. doi: 10.1097/JCP.0000000000001611. Epub 2022 Oct 3.
Results Reference
derived

Learn more about this trial

Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia

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